Is Rezafungin registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Rezafungin, including Rezzayo (200 mg, Powder for concentrate for solution for infusion, SAR 8947.00).

Is Rezafungin approved by the US FDA?

Drugs@FDA lists 1 application product line for Rezafungin, including REZZAYO (Prescription).

Is Rezafungin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Rezafungin: Rezzayo.

Are there safety signals or safety updates for Rezafungin?

US FDA: 1 entry (latest 2026-07-16).

Active substance

Rezafungin

SFDA 1
US FDA 1
EMA 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Rezzayo	200 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 8947.00	NCE · Prescription	Mundipharma GmbH	Valid

Indications — CHI Daman Drug Formulary

Invasive Candidiasis and Candidemia

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
REZZAYO	EQ 200MG BASE/VIAL	powder · intravenous	MUNDIPHARMA	Prescription	22 Mar 2023

EMA European Union — centrally authorised medicines

Rezzayo Mundipharma GmbH · Authorised · authorised 22 Dec 2023 · ATC J02AX08

Therapeutic indication (EMA)

Rezzayo is indicated for the treatment of invasive candidiasis in adults. Consideration should be given to official guidance on the appropriate use of antifungal agents.

Safety signals and safety-related labeling changes

US FDA 16 Jul 2026 REZZAYO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for rezafungin →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.